Package Insert: Information for the User

SeptaNasal 1 mg/ml + 50 mg/ml Nasal Spray Solution

xylometazoline hydrochloride / dexpanthenol

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

This medication contains xylometazoline hydrochloride and dexamethasone.

Xylometazoline hydrochloride causes a rapid constriction of the nasal blood vessels and reduces nasal mucosa inflammation and mucous secretion. This reduces nasal congestion sensation. Dexamethasone is a derivative of vitamin B5, which promotes healing and protects the nasal mucosa.

SeptaNasal is used for local and temporary relief of nasal congestion and mucosa nasal conditions with inflammation and/or small wounds, with or without crust formation in adults and adolescents over 12 years old.

No use SeptaNasal

• If you or your child are allergic to xylometazoline hydrochloride, dextromethorphan or any of the other ingredients in this medication (listed in section 6).
• If you have recently undergone surgery on your head (if you have undergone any cranial, transnasal or transoral surgery).
• If you have high blood pressure, especially if you have narrow-angle glaucoma.
• If you or your child have dry mucous membrane inflammation of the nose (dry rhinitis).
• If you are being treated with monoamine oxidase inhibitors (MAOIs) or if you have used MAOIs in the 2 weeks prior to starting treatment with this medication.
• If you are prone to inflammation of the blood vessels in your nose.
• If you or your child have undergone surgical removal of the pituitary gland or other surgery that exposes the meninges (the covering of the brain).

This medication should not be used in children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• You are being treated with antidepressants, monoamine oxidase inhibitors (MAOIs), phenothiazine (tranquilizer), methyldopa (to lower blood pressure) or other medications that may increase blood pressure.
• You have high intraocular pressure (glaucoma), especially if you have narrow-angle glaucoma.
• You have a severe cardiovascular disease or circulatory system disease (e.g. coronary heart disease, high blood pressure or long QT syndrome).
• You have ever experienced insomnia or dizziness when taking other sympathomimetic medications, such as those used to treat heart disease, low blood pressure or asthma.
• You have a metabolic disease (e.g. diabetes, porphyria, or increased activity of the thyroid gland that causes increased sweating, body temperature or heart rate).
• You have a tumor of the adrenal gland (pheochromocytoma).
• You have benign prostatic hyperplasia.

In any of the above cases, consult your doctor or pharmacist before starting to take this medication.

In rare cases, xylometazoline may increase nasal congestion instead of decreasing it; this is due to the temporary effects of xylometazoline and prolonged use may result in a rebound effect with vasodilation, congestion and rhinitis.

Rarely, insomnia may occur after using the medication. If this happens, avoid using it in the late afternoon or evening.

To prevent contagion, the medication should not be used by more than one person and the applicator should be cleaned with a clean, damp cloth after each use.

Children

SeptaNasal use is only indicated in children over 12 years old.

Use in people over 65 years old:

Consult your doctor or pharmacist as people over 65 years old are more sensitive to the effects of this medication.

Other medications and SeptaNasal

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

The use of this medication at the same time as some medications for depression (monoamine oxidase inhibitors of the type tranilcipromina or tricyclic antidepressants), as well as medications that increase blood pressure, may cause an increase in blood pressure due to the cardiovascular effects of these substances.

The use of this medication at the same time as other medications for the flu or cold and cough that contain sympathomimetics (medications used to treat nasal congestion such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may increase adverse reactions in the cardiovascular system and central nervous system.

Do not use medications to lower blood pressure (e.g. methyldopa) with xylometazoline due to its hypertensive effect.

Consult a doctor before using this medication if you or your child use any of the above medications.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy due to the lack of safety data in pregnant women.

This medication should not be used during breastfeeding, as the hydrochloride of xylometazoline is unknown to be excreted in breast milk.

Driving and operating machinery

This medication is not expected to affect your ability to drive or operate machinery if used as recommended. If you experience drowsiness or dizziness while using this medication, do not drive or operate hazardous tools or machinery.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents 12 years and older

The recommended dose is a spray in each nasal passage up to 3 times a day if necessary.

Do not use this medication for more than 3 days, unless your doctor has given you different instructions.

This medication can only be reused after a period of rest of several days. Do not exceed the recommended dose.

Administration Form

First, remove the protective cap from the sprayer.

Before the first use or if the sprayer has not been used for a prolonged period, press the head of the sprayer 5 times until a fine spray appears.

Insert the tip of the sprayer as straight as possible into one nasal passage and press the head of the sprayer once. Breathe gently through the nose while spraying the product. If necessary, repeat the procedure for the other nasal passage. After each use, clean the tip of the sprayer with a paper tissue and replace the protective cap on the sprayer.

Prolonged use or higher doses of this medication may cause chronic inflammation and also thinning (damage) of the nasal mucosa.

Patients with elevated intraocular pressure (glaucoma), especially narrow-angle glaucoma, should consult a doctor before using this medication.

Use in children and adolescents

SeptaNasal should not be administered to children under 12 years.

If you use more SeptaNasal than you should

• If you use more medication than you should or if you accidentally ingest large quantities, the following side effects may occur: pupil constriction (miosis), pupil dilation (mydriasis), fever, sweating, pale skin, blue discoloration of the lips (cyanosis), nausea, convulsions, cardiac and vascular disorders (increased heart rate, slow heart rate, arrhythmias, circulatory failure, cardiac arrest, high blood pressure (hypertension), respiratory disorders (pulmonary edema, respiratory problems) and mental disorders.

You may also experience drowsiness, a decrease in body temperature, heart rate, and blood pressure, respiratory arrest, and coma.

If you notice any of these symptoms, inform your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use SeptaNasal

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Rarely(may affect up to 1 in 100 people):

• allergic reaction, such as skin inflammation and mucous membrane inflammation, skin rash, itching.
• nasal bleeding.

Rare(may affect up to 1 in 1,000 people):

• palpitations (perception of heartbeats), tachycardia (rapid heartbeats), hypertension (elevated blood pressure).

Very Rare(may affect up to 1 in 10,000 people):

• anxiety, difficulty sleeping, hallucinations (especially in children).
• fatigue (drowsiness, sedation), headache, seizures (especially in children).
• cardiac rhythm disorders (arrhythmias).
• nasal mucosa inflammation (after discontinuing treatment).

Unknown Frequency(cannot be estimated from available data):

• nasal mucosa burning and dryness, sneezing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

After the first opening of the packaging, the product must be used within a period of 12 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the medication that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of SeptaNasal

• The active principles are hydrochloride of xylometazoline and dexamethasone.

Each ml of nasal spray solution contains 1 mg of hydrochloride of xylometazoline and 50 mg of dexamethasone.

One spray contains 0.1 ml of nasal spray solution with 0.1 mg of hydrochloride of xylometazoline and 5.0 mg of dexamethasone.

• The other components are dihydrogen phosphate of potassium, disodium dodecahydrate phosphate and water for injections.

Appearance of the product and contents of the packaging

The nasal spray solution is liquid, transparent and colorless.

SeptaNasal is available in boxes of 10 ml of nasal spray solution, in a plastic spray container with a spray pump.

10 ml of nasal spray solution are sufficient for 90 sprays.

Holder of the marketing authorization and responsible for manufacturing

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/